Chapter 4. Statistical Considerations in Analytical Method Validation
Bruno Boulanger[]
[] Bruno Boulanger is Manager, European Early Phase Statistics, Eli Lilly and Company, Belgium.
Viswanath Devanaryan []
[] Viswanath Devanaryan is Associate Director, Biostatistics and Research Decision Sciences, Merck, USA.
Walthère Dewé []
[] Walthère Dewée is Senior Research Scientist, Global Discovery and Development Statistics, Eli Lilly and Company, Belgium.
Wendell Smith []
[] Wendell Smith is Partner and Senior Statistician, Bowsher Brunelle Smith (B2S Consulting), USA.
In the context of a pre-study validation of an analytical method, this chapter describes some advanced statistical methodologies available in the literature and provides SAS code to calculate ...
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